Single lumen balloon catheter apparatus

ABSTRACT

A catheter useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein. The catheter includes a tubular body having a lumen extending from a first end thereof to a second end thereof. The lumen includes an external opening adjacent the first end for dispensing a diagnostic fluid into the interior of a subject uterus, and a balloon disposed marginally adjacent to the first end of the body for fluid sealing the interior of the subject uterus. The lumen further includes a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid. In most applications, the catheter can be combined with a syringe to form a catheter apparatus.

FIELD OF THE INVENTION

[0001] The present invention relates to catheters, and in particular, toa balloon-bearing single lumen catheter for injecting diagnostic fluidsinto a body cavity and a catheter apparatus employing same.

BACKGROUND OF THE INVENTION

[0002] Diagnostic procedures which require a non-surgical entry into theuterus are well known. One such procedure known ashysterosalpingography, is a radiographic method for imaging theanatomical structures of the uterus and fallopian tubes.Hysterosalpingography involves inserting a fine flexible catheterthrough the cervical canal and injecting a contrast medium, such as aniodinated fluid, into the uterus. Radiography is then carried out toprovide imaging information pertaining to the subject uterus.

[0003] Another well known diagnostic procedure which entails thenon-surgical entry into the uterus is called hysterosonography. Thisprocedure also employs a fine flexible catheter that is inserted intothe cervical canal of the uterus. The catheter in this procedure enablesthe physician or technician to inject a sterile saline solution into theuterus to expand it so that an ultrasound scanner can be used tosonographically observe the uterus.

[0004] The catheters used in both procedures typically have means forsealing off the uterus after injection of the fluid to prevent backflowinto the vaginal canal. One such means includes an inflatableintrauterine balloon made from an elastomeric material disposed adjacentthe distal tip of the catheter. The catheter includes a first lumen thatcommunicates with the interior of the balloon to enable inflation anddeflation with an inflation syringe, and second lumen that is open atthe distal tip of the catheter to enable injection of a desireddiagnostic fluid into the uterus with a injection syringe.

[0005] The balloon catheter is operated by inserting the distal tipthereof through the cervical canal and into the uterus with theintrauterine balloon deflated. The insertion of the distal tip operatesto position the deflated intrauterine balloon in the uterus. Oncepositioned, the inflation syringe is used to inflate the intrauterineballoon with air to seal block the cervical canal and the injectionsyringe is used to inject the desired diagnostic fluid into the uterus.

[0006] One problem associated with balloon catheters of this design isthat they are relatively expensive to manufacture because they includetwo lumens and double syringes. Therefore, a less expensive balloonbearing catheter is needed.

SUMMARY OF THE INVENTION

[0007] A catheter used for non-surgically entry into a uterus todispense a diagnostic fluid therein; the catheter comprising a tubularbody having a lumen extending from a first end thereof to a second endthereof. The lumen includes an external opening adjacent the first endfor dispensing a diagnostic fluid into the interior of a subject uterus,and a balloon disposed marginally adjacent to the first end of the bodyfor fluid sealing the interior of the subject uterus. The lumen furtherincludes a second opening in fluid communication with the interior ofthe balloon for inflation thereof with the diagnostic fluid.

[0008] The catheter is typically combined with a syringe to form acatheter apparatus if desired.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The advantages, nature, and various additional features of theinvention will appear more fully upon consideration of the illustrativeembodiments now to be described in detail in connection withaccompanying drawings wherein:

[0010]FIG. 1 is an elevational view of a catheter apparatus according toan embodiment of the invention;

[0011]FIG. 2 is a sectional view of the catheter of the apparatus;

[0012]FIG. 3A is a diagrammatic view of the catheter of the inventionanchored in the cervical canal of a subject uterus;

[0013]FIG. 3B is a diagrammatic view of the catheter of the inventionanchored in the uterine cavity of a subject uterus; and

[0014]FIG. 4 is an enlarged diagrammatic view of the distal portion ofthe catheter of the invention.

[0015] It should be understood that the drawings are for purposes ofillustrating the concepts of the invention and are not necessarily toscale.

DETAILED DESCRIPTION OF THE INVENTION

[0016]FIG. 1 shows a catheter apparatus according to an embodiment ofthe invention. The catheter apparatus 10 is an inline assembly comprisedof a flexible, single lumen catheter 11 and a conventional syringe 12.The catheter apparatus 10 is primarily intended for non-surgical entryinto the uterine cavity, however, one of ordinary skill in the art willrecognize its usefulness in other related procedures.

[0017] The catheter 11 of the apparatus 10 includes a flexible tubularbody 16 which is preferably made from a clear polyurethane or likematerial. The body 16 has a distal end 17 and proximal end 18 and isthreadedly disposed in a semi-rigid sheath 13 which is preferably madefrom polypropylene or any other suitable material. The sheath 13 has adistal end 24, a proximal end 25, and a length which is about 40%percent less than the length of the catheter body 16. The sheath 13 canbe slidably moved back and forth along the catheter body 16 to uncoverthe distal portion of the body 16 to allow it to bend and flex freely orto cover it to prevent bending and flexing thus aiding the insertion ofthe catheter 11 in the vaginal canal. A conventional female Luer hubconnector 14 is provided at the proximal end 18 of the catheter body 16for detachably fluid coupling the syringe 12 (which should be equippedwith a male Luer connector) to the catheter 11. An inflatable balloon 20(shown in the deflated state) is affixed to and encloses a marginaldistal end portion of the body 16. The balloon 20 can be of the typedescribed in U.S. Pat. No. 5,624,399 issued to Bernard Ackerman thedisclosure of which is incorporated herein by reference.

[0018] The balloon 20 taught in U.S. Pat. No. 5,624,399 is typicallyconstructed from an elastomeric material such as polyurethane or anyother elastomeric material having a Shure A durometer of betweenapproximately 70 and 95. U.S. Pat. No. 5,624,399 further teachesattaching the balloon 20 to the body 16 so that its longitudinal axis Lis longer than its transverse axis T upon initial inflation thereof.This allows the balloon 20 to be progressively transformed from anellipsoidal shape to a spherical shape with increasing inflationpressure. The balloon 20 in the ellipsoidal shape as shown in FIG. 3A,can be used for occluding the cervical canal 32 of a subject uterus 31thus preventing obstruction of the uterus 31 during imaging. If painand/or cramping is experienced with the balloon 20 in the cervical canal32, it can be moved into the uterine cavity 33 of the subject uterus 31and further expanded into the spherical shape to block the opening 34 ofthe cervical canal 32 as shown in FIG. 3B to obviate the pain and/orcramping.

[0019] It should be understood that other embodiments of the inventioncan employ more conventional balloon designs. Such balloon designstypically inflate into a spherical shape and are made from latex.

[0020]FIG. 2 shows a cross-sectional view through the catheter 11 of theapparatus 10. As can be seen, the body 16 of the catheter 11 isconstructed with a single lumen 21 that extends virtually the entirelength thereof. The wall 19 of the lumen 21 includes a first slit 22(best shown in FIG. 4) adjacent to the distal end 17 of the body 16. Thefirst slit 22 allows the lumen 21 to communicate with the externalenvironment to provide a fluid communication path for injecting adiagnostic fluid such as saline or a contrast dye into a the uterinecavity of a subject uterus. The lumen 21 also communicates with theinterior of balloon 20 via a second slit 23 (best shown in FIG. 4)provided in the wall 19 of the lumen 21. The second slit 23 is equal toor up to 28 percent larger in area than the first slit 22 to provide acommunication path for inflating the balloon 20 with diagnostic fluid aswill be explained further on. In other embodiments of the invention,either one or both of the slits 22, 23 can be replaced with acorrespondingly placed aperture(s).

[0021] The apparatus 10 is typically operated by moving the sheath 13toward the distal end 17 of the catheter 11, to cover the most of thedistal portion of the catheter body 16 (the balloon 20 should bedeflated). The catheter 11 is then inserted into the vaginal canal sothat the distal end 17 of the catheter 11 just enters the cervical canalof a subject uterus and the distal end 24 of the sheath 13 abuts againstthe end of the cervix. The catheter 11 is then threaded through thesheath 13 to position the balloon 20 in the cervical canal, or just pastthe cervical canal inside the uterine cavity of the uterus (FIG. 3A).

[0022] The syringe 12 of the apparatus 10, which is filled with adiagnostic fluid such as saline or a contrast dye, is then operated toinject the diagnostic fluid into the uterine cavity of the uterus. Thefluid pressure generated within the lumen 21 by the operation of thesyringe 12 causes the first slit 22 at the distal end 17 of the catheterbody 16 to open and allow the diagnostic fluid to flow from the catheter11 into the uterine cavity of the uterus. At the same time as the uterusis being filled with the fluid, back-pressure within the lumen 21 of thecatheter 11 caused by restricted fluid flow through the first slit 22causes the second slit 23 to open to allow fluid to enter and inflatethe balloon 20, thus preventing leakage of fluid through the cervicalcanal.

[0023] Once the balloon 20 is inflated, the slits 22, 23 operate ascheck valves by automatically closing to prevent the balloon 20 fromdeflating. The inflated balloon 20 locks the position of the apparatus10 and seals the uterine cavity to prevent leakage of the diagnosticfluid therefrom. Radiography or sonography can then be performed toprovide imaging information pertaining to the subject uterus orfallopian tubes.

[0024] When it is desirable to deflate the balloon 20, the syringe 12 isuncoupled from the catheter 11 and the catheter is withdrawn slightlythrough the cervix. This causes the muscular tissue of the cervix tocompress the balloon 20 slightly thus forcing the fluid in the balloonback into the lumen 21 of the catheter 11 through the slit 23. Once theballoon 20 is deflated, the catheter 11 of the apparatus 10 can be fullywithdrawn from the uterus through the cervical canal.

[0025] While the foregoing invention has been described with referenceto the above embodiments, various modifications and changes can be madewithout departing from the spirit of the invention. Accordingly, allsuch modifications and changes are considered to be within the scope ofthe appended claims.

1. A catheter useful for non-surgical entry into a uterus to dispense adiagnostic fluid therein, the catheter comprising: a tubular body havinga single lumen extending from a first end thereof to a second endthereof, the lumen having an external opening adjacent the first end fordispensing a diagnostic fluid into the interior of a subject uterus; anda balloon disposed marginally adjacent to the first end of the body forfluid sealing the interior of the subject uterus; the lumen having asecond opening in fluid communication with the interior of the balloonfor inflation thereof with the diagnostic fluid; wherein the externalopening adjacent the first end generates a back-flow within the lumenwhich causes the fluid to enter and inflate the balloon through thesecond opening.
 2. The catheter according to claim 1, wherein the bodyis flexible.
 3. The catheter according to claim 2, further comprising amovable sheath that can be moved to a first position to cover a portionof the body to add rigidity thereto thus aiding in the insertion of thecatheter, and which can be moved to a second position to uncover theportion of the body thus allowing it to bend and flex freely.
 4. Thecatheter according to claim 1, wherein the balloon can be sequentiallyinflated into first and second predetermined shapes.
 5. The catheteraccording to claim 4, wherein the first predetermined shape issubstantially elliptical and the second predetermined shape issubstantially spherical.
 6. The catheter according to claim 4, whereinthe balloon is made from polyurethane.
 7. The catheter according toclaim 1, wherein the balloon is made from polyurethane.
 8. The catheteraccording to claim 1, wherein the second opening prevents fluidback-flow in the lumen to maintain inflation of the balloon.
 9. Acatheter apparatus useful for non-surgical entry into a uterus todispense a diagnostic fluid therein, the catheter apparatus comprising:a catheter; a syringe for delivering the diagnostic fluid into thecatheter; the catheter having a balloon disposed marginally adjacent toa first end thereof for fluid sealing the interior of the subjectuterus, a single lumen extending from the first end to a second end ofthe catheter, the lumen having an external opening adjacent the firstend for dispensing the diagnostic fluid into the interior of a subjectuterus and a second opening in fluid communication with the interior ofthe balloon for inflation thereof with the diagnostic fluid; wherein theexternal opening adjacent the first end generates a back-flow within thelumen which causes the fluid to enter and inflate the balloon throughthe second opening.
 10. The catheter apparatus according to claim 9,wherein the second opening prevents fluid back-flow in the lumen tomaintain inflation of the balloon.
 11. The catheter apparatus accordingto claim 9, wherein the catheter is flexible.
 12. The catheter apparatusaccording to claim 11, further comprising a movable sheath that can bemoved to a first position to cover a portion of the body to add rigiditythereto thus aiding in the insertion of the catheter, and which can bemoved to a second position to uncover the portion of the body thusallowing it to bend and flex freely.
 13. The catheter apparatusaccording to claim 9, wherein the balloon can be sequentially inflatedinto first and second predetermined shapes.
 14. The catheter apparatusaccording to claim 13, wherein the first predetermined shape issubstantially elliptical and the second predetermined shape issubstantially spherical.
 15. The catheter apparatus according to claim13, wherein the balloon is made from polyurethane.
 16. The catheterapparatus according to claim 9, wherein the balloon is made frompolyurethane.
 17. A method for making a catheter which is useful fornon-surgical entry into a uterus to dispense a diagnostic fluid therein,the method comprising the steps of: providing a tubular body having asingle lumen extending from a first end thereof to a second end thereof,creating an external opening adjacent the first end of the body, theexternal opening for dispensing a diagnostic fluid into the interior ofa subject uterus; attaching a balloon marginally adjacent to the firstend of the body, the balloon for fluid sealing the interior of thesubject uterus; and creating a second opening in the lumen which is influid communication with the interior of the balloon for inflationthereof with the diagnostic fluid.
 18. The method according to claim 17,further comprising the step of providing a syringe that delivers thediagnostic fluid into the catheter, the syringe and the catheter forminga catheter apparatus.
 19. The method according to claim 17, wherein thesecond opening prevents fluid backflow in the lumen to maintaininflation of the balloon.
 20. The method according to claim 17, whereinthe catheter is flexible.
 21. The method according to claim 20, furthercomprising the step of providing a movable sheath that can be moved to afirst position to cover a portion of the body to add rigidity theretothus aiding in the insertion of the catheter, and which can be moved toa second position to uncover the portion of the body thus allowing it tobend and flex freely.
 22. The catheter according to claim 1, wherein theexternal opening has a predetermined area and the second opening has apredetermined area, the predetermined area of the second opening beinggreater than the predetermined area of the external opening.
 23. Thecatheter apparatus according to claim 9, wherein the external openinghas a predetermined area and the second opening has a predeterminedarea, the predetermined area of the second opening being greater thanthe predetermined area of the second opening.